Response of Children With Atopic Dermatitis (Eczema) to Eucrisa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04023084|
Recruitment Status : Not yet recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis Eczema||Drug: Crisaborole||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||children diagnosed with AD and aged 5-17 years old will receive intervention|
|Masking:||None (Open Label)|
|Official Title:||PDE4A Expression as a Biomarker of Responsiveness to Eucrisa|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Atopic Dermatitis Group
Receive crisaborole intervention
Crisaborole 2% topical ointment applied twice daily to affected area(s) for 28 days
Other Name: Eucrisa
- Changes in expression levels of biomarkers in responder versus non responder groups [ Time Frame: Baseline (Day 1) and Day 28 ]The baseline mean expression levels of biomarkers extracted from tape strips (TH2 (IL13, IL4R, CCL26), TH17/22 (IL36G), itch (ENKUR), epidermal genes (FLG, LOR and S100A9) and PDE4A will be compared in clinical "responder" versus "non-responder" groups. Groups will be defined by the primary clinical outcome of disease severity improvement by clinician assessment. Clinicians will assess disease severity by Investigator's Static Global Assessment (ISGA) and Eczema Area and Severity Index (EASI) score.
- Changes in Quality of life (anxiety, depressive symptoms, fatigue, mobility, pain interference, peer relationships) as assessed by PROMIS Pediatric Profile 25 and Correlation of changes with clinical responsiveness and biomarker PDE4A expression levels [ Time Frame: Baseline (Day 1) and Day 28 ]Changes in quality of life will be measured by comparing standardized PROMIS T-scores for each domain at Day 28 with baseline. The PROMIS Pediatric Profile 25 is a 25-item questionnaire and assesses anxiety, depressive symptoms, fatigue, mobility, pain interference, and peer relationships. Each item has five response options. The HealthMeasures Scoring Service will be used to calculate T-scores for each domain. A T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher T-score represents more of the concept being measured. Responsiveness will be determined by comparing clinician-assessed disease severity by ISGA and EASI scores at baseline and Day 28.
- Changes in Quality of life (symptoms and feelings, leisure, school or holidays, personal relationships, sleep, treatment) as assessed by CDLQI and Correlation of Quality of life changes with clinical responsiveness and biomarker PDE4A expression levels [ Time Frame: Baseline (Day 1) and Day 28 ]Changes in quality of life will be measured by comparing CDLQI scores at Day 28 with baseline. The CDLQI is a 10-item questionnaire assessing symptoms and feelings, leisure, school or holidays, personal relationships, sleep, and treatment. Scores range from 0 to 30 and are calculated by summing the scores of each question. The higher the score, the more impaired quality of life. Responsiveness will be determined by comparing ISGA and EASI scores at baseline and Day 28.
- Correlation of TEWL with clinical responsiveness and biomarker PDE4A expression levels [ Time Frame: Baseline (Day 1) and Day 28 ]Diffusion of water through the skin is measured using the AquaFlux instrument. Responsiveness will be determined by comparing ISGA and EASI scores at baseline and Day 28.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023084
|Contact: Jennifer Lorfirstname.lastname@example.org|
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital of Chicago||Not yet recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Jennifer Lor 312-227-6010 email@example.com|
|Principal Investigator: Anna Fishbein, MD|
|Principal Investigator:||Anna Fishbein, MD||Ann & Robert H Lurie Children's Hospital of Chicago|